FDA Issues Breakthrough Designations

September 09, 2025 An Ruwaito ta hanyar AI

The FDA granted several breakthrough device designations in September 2025 for innovative medical technologies. These designations expedite the development and review of devices addressing unmet needs. Updates include new approvals and predetermined change control plans.

AI Stethoscope Diagnoses Quickly

An AI-powered stethoscope was introduced, capable of diagnosing three conditions in 15 seconds. This innovation enhances point-of-care diagnostics in clinical settings. It was featured among key medical breakthroughs of the week.

New Advances in Diabetes Management Technologies

September 13, 2025 An Ruwaito ta hanyar AI

Recent developments in diabetes care include smarter insulin delivery systems and an AI-paired artificial pancreas, highlighted on September 11, 2025.

Federal judge upholds FDA authority over lab-developed tests

A U.S. federal judge has ruled that the Food and Drug Administration (FDA) possesses the authority to regulate lab-developed tests (LDTs) as medical devices. This decision comes amid ongoing debates over the oversight of in-house diagnostic tools used by clinical laboratories.